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Terminated

Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)

FDA Recall Z-1122-2015 · Posted 2015-02-17

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2015-01-09
Date Terminated2015-10-22
Product Quantity17

Reason for Recall

Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.

Firm Action

Biomet notified all domestic and foreign customers via FEDEx overnight on 1/9/2015. Response forms were provided, customers were instructed to notify hospital personnel if product was further distributed, and remove recalled products from circulation. Replacement parts were made available, customers may contact Audrey Daenzer, Field Action Specialist, Regulatory Compliance Biomet, Inc., [email protected], or 574-372-1570 Monday- Friday 8 AM to 5 PM.

Root Cause

Packaging process control

Distribution Pattern

Distributed in the states of VA and TX and the country of Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030055MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTSBiomet, Inc. · 2003-08-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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